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This study is to evaluate the efficacy and safety of BCMA-PD1-CART cells therapy for patients with Relapsed/Refractory Multiple Myeloma.

This study was a single-center, open-label, single-arm, non-randomized clinical trial, which was divided into 3 groups by infusion dose level. Firstly, each dose group has 3 patients. The pretreatment regimen of cyclophosphamide (25mg/m2 for 3 consecutive days) and fludarabine (10mg/kg for 3 consecutive days) was given before CART cells were reinfused. CART cells were reinfused on the third day after the pretreatment. If no serious side effects emerges in the group, then the next group uses the subsequent higher dose. If serious side effects emerges in a single patient in any dose level, 3 more patients will be enrolled to the same dose level. After 9 or more patients, we select the safest dose and recruit more patients for CART test to explore its effectiveness.

BCMA-PD1-CART Cell

Quanshun Wang

Wenshuai Zheng

Lixun Guan

Zhenyang Gu

Lu Wang

Yuanyuan Xu

Yalei Hu

Zhenyang Guan

This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of BCMA-PD1-CART cells therapy for patients with relapsed/refractory Multiple Myeloma.

Previous studies have found that multiple myeloma cells express PD-L1 at a high level. Therefore, the combination of anti-PD-1 or PD-L1 antibodies with CART therapy may further improve the clinical efficacy of CART cell for multiple myeloma.

The investigators screened PD-1 mutant that have high affinity bind with the PD-L1 ligand, and the affinity of the prepared mutant PD-1 Fc fusion protein to bind to PD-L1 reached clinical anti-PD-L1 antibody levels. The investigators prepared BCMA CART cells which secretes the mutant PD-1Fc fusion protein, and the prepared CART cell culture supernatant can well block the binding of PD-L1 to PD-1. Preclinical studies have shown that BCMA CART cells secreting mutant PD-1Fc fusion protein have a superior killing effect on PD-L1 positive multiple myeloma tumor cells to BCMA CART cells which does not express PD-1 fusion protein.

The trial was conducted to explore the safety and efficacy of BCMA-PD1-CART cells in Relapsed/Refractory Multiple Myeloma.

Safety and Efficiency Study of BCMA-PD1-CART Cells in Relapsed/Refractory Multiple Myeloma

Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).

ORR will be assessed from the first CAR-T cell infusion to death or last follow-up

OS will be assessed from the first CAR-T cell infusion to death or last follow-up

PFS will be assessed from the first CAR-T cell infusion to death or last follow-up

In vivo (peripheral blood) rate of BCMA-PD1-CARTcells were determined by means of flow cytometry.

In vivo (peripheral blood) quantity of BCMA-PD1-CART cells copies copies were determined by means of qPCR.

Chinese PLA General Hospital

Chief of Hematology Department of Hainan Hospital of PLA General Hospital; Vice Chief of Hematology Department of PLA General Hospital

Vaccines

Immunoglobulin Idiotypes

Antibodies

Immunoglobulins

Immunoglobulins, Intravenous

Immunologic Factors

Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks

autologous idiotype-protein pulsed dendritic cells

Susanne Gretzinger, MD

Patients with stage-I multiple myeloma are treated with a vaccine made from their own immune cells (dendritic cells) and their own myeloma protein. Vaccinations are given on 5 occasions every 4 weeks. The aim is to induce an immune reaction against the malignant myeloma cells in order to slow down or cure the disease.

Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma

Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma

University Hospital Carl Gustav Carus

Susanne Gretzinger

allogeneic hematopoietic SCT

Nicolaus Kroeger, Prof. Dr.

To evaluate the feasibility and efficacy of a autologous stem cell transplantation followed by a Melphalan/ Fludarabine based dose-reduced allograft from HLA-identical and HLA-compatible unrelated donor in patients with Multiple Myeloma. In those with non complete remission DLI and/ or new agents such as Bortezomib, Thalidomid or Lenalidomide can be used to upgrade remission.

Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma

Dose-Reduced Allogeneic Stem Cell Transplantation as Induction of a Graft-Versus-Myeloma-Effect After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma Stage II/III

Universitätsklinikum Hamburg-Eppendorf

Prof. Dr. N. Kroeger

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficiency Study of BCMA-PD1-CART Cells in Relapsed/Refractory Multiple Myeloma	NCT04162119	Multiple Myelom...	BCMA-PD1-CART C...	14 Years - 80 Years	Chinese PLA General Hospital
Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma	NCT00988312	Multiple Myelom... Plasmocytoma	autologous idio...	18 Years - 70 Years	University Hospital Carl Gustav Carus
Safety and Efficiency Study of BCMA-PD1-CART Cells in Relapsed/Refractory Multiple Myeloma	NCT04162119	Multiple Myelom...	BCMA-PD1-CART C...	14 Years - 80 Years	Chinese PLA General Hospital
Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma	NCT00781170	Multiple Myelom... Stem Cell Trans...	allogeneic hema...	18 Years - 66 Years	Universitätsklinikum Hamburg-Eppendorf
Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma	NCT00781170	Multiple Myelom... Stem Cell Trans...	allogeneic hema...	18 Years - 66 Years	Universitätsklinikum Hamburg-Eppendorf

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